MedComp 14F Hemodialysis Catheter Kits Have Wrong Introducer Type
MedComp recalls 14F x 24CM SLX Double Lumen Hemodialysis catheter kits that contain a non-valved introducer instead of the labeled valved type. This could lead to complications during dialysis procedures.
Lower-risk recall
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
Contact the company
What happened, in plain English
MedComp is recalling 14F x 24CM SLX Double Lumen Hemodialysis catheter insertion kits that contain a non-valved introducer instead of the labeled valved type. This mismatch could cause complications during dialysis procedures if used incorrectly. Read more at govinfonow.com/recall/68842-medcomp-14f-hemodialysis-catheter-kits-have-wrong-introducer-type.
Source Summary by GovInfoNow · govinfonow.com/recall/68842-medcomp-14f-hemodialysis-catheter-kits-have-wrong-introducer-type · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2216-2019
Cite this page
“MedComp 14F Hemodialysis Catheter Kits Have Wrong Introducer Type.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68842-medcomp-14f-hemodialysis-catheter-kits-have-wrong-introducer-type. Based on FDA recall #Z-2216-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2216-2019%22&limit=1).
Why it’s dangerous
The kits are labeled as containing a 15F "valved" peelable introducer, but actually contain a 15F "non-valved" peelable introducer. This difference affects how the catheter is inserted, potentially causing complications during dialysis procedures.
Who’s affected
Hemodialysis patients and healthcare providers who use the recalled MedComp catheter insertion kits. Those most at risk are patients receiving dialysis treatments with these kits.
How to tell if you have this one
Check for the product name: 14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits. The item number is MC061424. These kits were sold with the specific model codes listed in the description.
- Brand
MedComp- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US Nationwide Distribution CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.
| Recall number | Product, codes & lots |
|---|---|
| Z-2215-2019 | 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid for introducing a hemodialysis catheter; MCAK580 MCAS990 MCAY850 MCBA850 MCBH150 MCBN670 MCBY930 MCCC770 MCCK640 MCCN740 MCCR330 MCCW790 MCDC600 MCDK990 MCDR410 MCFB340 MCFG840 MCFL120 MCFP220 MCFT420 MCFZ280 MKAF340 MKAG480 MKAN280 MKAT110 MKAX330 MKBA730 MKBH920 MKBN710 MKBX790 MMAB370 MMAD450 MMAQ940 |
| Z-2216-2019 | 14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424 Product Usage: An aid for introducing a hemodialysis catheter; MCAL430 MCAT000 MCBM770 MCBS380 MCCC840 MCCM930 MCCS360 MCCZ450 MCDC580 MCDN120 MCDR420 MCFB350 MCFG980 MCFM410 MCFP230 MCFT430 MCFZ290 MKAF350 MKAG490 MKAM210 MKAR120 MKBA200 MKBL090 MKBL220 MKBV580 MMAB710 MMAM070 MMAQ950 |
| Z-2217-2019 | 14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 Product Usage: An aid for introducing a hemodialysis catheter; MCAM240 MCBL480 MCBS870 MCCF480 MCCJ320 MCCW690 MCCZ500 MCFG830 MCFR160 MCFS760 MCFZ360 MKAJ330 MKAR130 MKBL500 MKBX060 MMAB730 |
What to do — step by step
Check Kit Label
Look for the item number MC061424 on the kit packaging or label.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 20 states.
FDA distribution: “US Nationwide Distribution CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Mississippi, Missouri, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, West Virginia.
Recall timeline
FDA terminated this recall 5 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2216-2019 (March 13, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2216-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.